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Clinical Trials/NCT01872767
NCT01872767
Completed
Not Applicable

Spectrum, Profile and Outcome of Infections in Patients With Cirrhosis and/ or Acute on Chronic Liver Failure Admitted in Liver Specialty ICU (Intensive Care Unit)- An Observational Study

Institute of Liver and Biliary Sciences, India1 site in 1 country522 target enrollmentJune 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cirrhosis
Sponsor
Institute of Liver and Biliary Sciences, India
Enrollment
522
Locations
1
Primary Endpoint
Mortality within 1 month during ICU (Intensive Care Unit) stay.
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

After successful screening diagnosis of cirrhosis and/or acute or chronic liver failure will be made. These patients will undergo detail clinical, biochemical and microbiological examination at baseline. Clinical examination and Biochemical evaluation will be done daily and signs of infection will be noted. Patients will undergo microbiological screening for infection every 48 hours. Patients suspected or diagnosed to be suffering from infections will be treated as per ILBS (Institute of Liver and Biliary Sciences) antibiotic policy. Site and etiology (bacterial and/or fungal) of infections will be noted in all patients at admission in liver specialty ICU (Intensive Care Unit) and during the ICU (Intensive Care Unit) stay. All the patients will be followed until discharge or death in ICU (Intensive Care Unit).

Registry
clinicaltrials.gov
Start Date
June 2013
End Date
November 2014
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • A clinical, radiological or histological diagnosis of cirrhosis and/or ACLF (Acute on Chronic Liver Failure).
  • Age \> 18years

Exclusion Criteria

  • Previous liver transplantation.
  • Patients who died within 8 hours of ICU (Intensive Care Unit) admission.
  • Acute liver failure
  • Lack of consent
  • Patient on steroids/ or any other immunosuppressive medication

Outcomes

Primary Outcomes

Mortality within 1 month during ICU (Intensive Care Unit) stay.

Time Frame: 30 days

Secondary Outcomes

  • Number of days stayed in ICU (Intensive Care Unit).(30 days)
  • Proportion of patients with organ failure.(30 days)
  • Risk factors determination in development of multidrug resistance bacteria.Risk factors are defined as Nosocomial infection,Recent Hospitalization, recent antibiotic usage, SBP (spontaneous bacterial peritonitis)prophylaxis, diabetes etc(30 days)

Study Sites (1)

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